MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VNMC4646C218TE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Valiant navion stent grafts were implanted during the endovascular treatment of a 50mm thoracic aortic aneurysm.It was reported approximately 3 years post the index procedure, the patient presented emergently experiencing abdominal pain.Ct imaging showed both a stent fracture and a type iiib endoleak in the navion graft vnmc4040c218te (b)(6).The diameter at the aortic arch was 17mm. 6 days later intervention was performed by relining the valiant navion stent graft with two non-mdt stents to resolve the endoleak.Corelab have reviewed ct imaging from the date the patient presented emergently.A type new iiib endoleak was identified in the stent graft vnmc4040c218te (b)(6).Fractures were also noted on ring 5 & ring 6 on the stent vnmc4040c218te (b)(6).Stent ring enlargement of +3.4mm on ring 5, of +6.7mm on ring 6, +3.0mm on ring 11 were noted on stent graft vnmc4040c218te (b)(6).Stent ring enlargement of + 3.6mm on ring 4 were also noted on vnmc4646c218te (b)(6).No stent ring migration was reported.The maximum aortic diameter measured 103mm.Per the physician the cause of the stent fracture and type iiib endoleak is related to a product defect.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT NAVION
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18948517
• MDR Text Key: 338210147
• Report Number: 9612164-2024-01369
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: VNMC4646C218TE
• Device Catalogue Number: VNMC4646C218TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005364322-02-19-2021-00
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male